Field of the Invention
This invention relates generally to hemostatic and antimicrobial barrier composition that achieves persistent antimicrobial properties by trapping the antimicrobial agent in a seal formed by the interaction of the hemostatic agent and blood and/or exudates, and particularly to a hemostatic composition comprising a ferrate compound and a cationic ion exchange resin with an antimicrobial agent, preferably povidone iodine which is hemostatic, antimicrobial and serves as an exudent.
Description of Related Art
Povidone iodine (PI) is well known as a broad spectrum, fast-acting antimicrobial compound. The USFDA Temporary Final monograph, incorporated in its entirety by reference, describes the efficacy of 5 to 10% PI solutions as an antimicrobial active.
Potassium ferrate (ferrate) is also a well-known disinfectant compound as a result of its very strong oxidation potential, disclosed in U.S. Pat. Nos. 6,187,347, 6,267,896 and 6,521,265 by Patterson et al. incorporated in their entirety.
Mixtures of ferrate and dry resin are also well known, disclosed in Patterson et al. in U.S. Pat. No. 6,187,347 and sold commercially as BIOSEAL (now WOUNDSEAL) powder. Mixtures of ferrate and dry acidic cationic exchange resin (1:7 ratio) are used as a safe and effective hemostasis powder. This compound is formed of a salt taken from the group consisting of H, Li, Na, K, Rb, Cs and Fr. However, to decrease or eliminate stringing sensation, the compound may be formed having a salt taken from the group consisting of Be, Mg, Ca, Sr, Ba, Ra, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Ga, Ge, Zr, Nb, Mo, Tc, Ru, Rh, Pd, Ag, Cd, In, Sn, Hf, Ta, W, Re, Os, Ir, Pt, Au, Hg, Tl, Pb, Bi, Al, As, NH4 and N(C4H9)4. The preferred composition also includes a cation exchange material such as sulfonated ion exchange resin as an admixture which will hydrate in the presence of blood and other body fluids to produce Fe+++ thereby promoting clotting of the blood and body fluid and to produce oxygen.
BIOSEAL (now WOUNDSEAL) trademarks of Biolife, L.L.C. of Florida is an amazingly effective antibacterial powder. It dries colonizing bacteria and extracts cations from the cell wall, replacing the cation with a proton and dropping the pH to about 2. It is well known that most bacteria are killed at that pH. Testing shows a slight kill for Candida, but essentially no kill for Aspergillus. Thus the BIOSEAL (now WOUNDSEAL) powder would have antibacterial efficacy, but not antimicrobial efficacy.
Other antimicrobial actives, such as chlorhexidine gluconate (CHG), are reported to have antibacterial and antimicrobial efficacy. CHG is also reported to be more effective than povidone iodine by the Centers for Disease Control (CDC). If an iodine product is to be competitive, it has to be better than CHG, cheaper, or have additional benefits that CHG does not have. For example, CHG loses efficacy when there is modest bioburden in and around the treated site; iodine does not. CDC guidelines for BIOPATCH, a 2% CHG-impregnated patch, require a dressing change if there is oozing.
A product that provides for hemostasis, absorbing ooze without compromising antimicrobial efficacy, and is also a powder would be particularly advantageous.
The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art upon a reading of the specification and a study of the drawings.